UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044814 |
|---|---|
| Receipt number | R000050263 |
| Scientific Title | A study of Japanese translation and reliability evaluation of the Primary Lateral Sclerosis Functional Rating Scale (PLSFRS) for Primary Lateral Sclerosis (PLS) |
| Date of disclosure of the study information | 2021/07/10 |
| Last modified on | 2024/01/10 09:55:31 |
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Basic information
Public title
A study of Japanese translation and reliability evaluation of the Primary Lateral Sclerosis Functional Rating Scale (PLSFRS) for Primary Lateral Sclerosis (PLS)
Acronym
PLS validation study
Scientific Title
A study of Japanese translation and reliability evaluation of the Primary Lateral Sclerosis Functional Rating Scale (PLSFRS) for Primary Lateral Sclerosis (PLS)
Scientific Title:Acronym
PLS validation study
Region
| Japan |
Condition
Condition
Primary Lateral Sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate by face-to-face examination and telephone listening consistent in addition to the evaluation of reliability by making a Japanese version after translating PLSFRS into Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate consistency of scores between evaluators, intra-rater reliability, face-to-face consultation, and telephone listening for all 12 items of PLSFRS and their total scores.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Upper motor neuron dysfunction of unknown cause are observed in at least two of the three regions of cranial nerves, upper limbs, and lower limbs regardless of the duration of illness, and needle electromyography shows normal or active lower motor neuron lesions. Patients meet all of the following.
1) Japanese is the first language.
2) You can sign the consent form. If you cannot sign due to weakness of the upper limbs, or if you cannot answer due to dysarthria, the signature of their substitute is acceptable.
3) Age at diagnosis is 20 years or older
4) No family history or consanguineous marriage.
Key exclusion criteria
1) If you have cognitive decline or deafness including their substitute.
2) When the researchers decide that he/she cannot express his/her intention accurately.
3) If you do not agree to this study.
4) In cases of death during the course
5) When the researchers judge inappropriate.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Yanagihashi |
Organization
Toho University Faculty of Medicine
Division name
Department of Neurology
Zip code
143-8541
Address
6-11-1 Omorinishi Ota-ku, Tokyo, Japan
TEL
0337624151
masaru.yanagihashi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Yanagihashi |
Organization
Toho University Faculty of Medicine
Division name
Department of Neurology
Zip code
143-8541
Address
6-11-1 Omorinishi Ota-ku, Tokyo, Japan
TEL
0337624151
Homepage URL
masaru.yanagihashi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Toho University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Neurology, Fukushima Medical University School of Medicine, Fukushima, Japan.
Rehabilitation Center, Jichi Medical University Hospital, Shimotsuke, Japan.
Department of Neurology, Tokyo Metropolitan Neurological Hospital, Tokyo, Japan.
Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center
Address
6-11-1 Omorinishi Ota-ku, Tokyo, Japan
Tel
0337624151
masaru.yanagihashi@med.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
The quadratic weighted kappa coefficient on intra-rater and inter-rater about each item are substantial agreement (intra-rater; 0.691-1.000, inter-rater; 0.634-1.000). Moreover, the intraclass correlation coefficient (ICC) was 0.997 (95% CI, 0.992-0.999)
Results date posted
| 2023 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unexplained upper motor neuron disorders in at least two of the three regions of the brain, upper limbs, and lower limbs regardless of the duration of the disease.
Normal needle electromyography, or no evidence of active lower motor neuron disorders
1) Japanese
2) Able to sign a consent form (if unable to sign due to muscle weakness in the upper extremities, or unable to respond due to dysarthria, writing on behalf of the patient is acceptable)
3) 20 years of age or older.
4) No family history or consanguinity
Participant flow
The evaluation of PLSFRS is performed by the face-to-face examination by the first evaluator at the time of registration and 8 weeks later, followed by the face-to-face examination and the telephone interview by another evaluator 4 weeks after the registration.
Adverse events
No adverse events in evaluation occurred
Outcome measures
1,Language
2,Salivation
3,Swallowing
4,Handwriting
5,Cutting food and handling utensils
6,Dressing and hygiene
7,Turning in bed and adjusting bedclothes
8,Walking
9,Climbing Stairs
R-1 Dyspnea
R-2 Orthopnea
R-3 Respiratory insufficiency
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Register patients with PLS who meet the selection criteria among the patients who visited our facility.
For registered patients, we evaluate about twelve items,speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing and hygiene, turning in bed and adjusting bedclothes, walking, climbing stairs, dyspnea, orthopnea and respiratory insufficiency.
Except for orthopnea and respiratory insufficiency, each is evaluated on a 7-point scale of 0 to 6 points, and orthopnea, respiratory insufficiency are evaluated on a 5-point scale of 0 to 4 points, respectively.
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050263
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